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1.
CA Cancer J Clin ; 74(4): 383-396, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38703384

RESUMO

Cancer mortality rates have declined during the last 28 years, but that process is not equitably shared. Disparities in cancer outcomes by race, ethnicity, socioeconomic status, sexual orientation and gender identity, and geographic location persist across the cancer care continuum. Consequently, community outreach and engagement (COE) efforts within National Cancer Institute-Designated Cancer Center (NCI-DCC) catchment areas have intensified during the last 10 years as has the emphasis on COE and catchment areas in NCI's Cancer Center Support Grant applications. This review article attempts to provide a historic perspective of COE within NCI-DCCs. Improving COE has long been an important initiative for the NCI, but it was not until 2012 and 2016 that NCI-DCCs were required to define their catchment areas rigorously and to provide specific descriptions of COE interventions, respectively. NCI-DCCs had previously lacked adequate focus on the inclusion of historically marginalized patients in cancer innovation efforts. Integrating COE efforts throughout the research and operational aspects of the cancer centers, at both the patient and community levels, will expand the footprint of COE efforts within NCI-DCCs. Achieving this change requires sustained commitment by the centers to adjust their activities and improve access and outcomes for historically marginalized communities.


Assuntos
Institutos de Câncer , Relações Comunidade-Instituição , National Cancer Institute (U.S.) , Neoplasias , Humanos , Estados Unidos/epidemiologia , Neoplasias/terapia , Neoplasias/epidemiologia , Institutos de Câncer/organização & administração , Disparidades em Assistência à Saúde
2.
N Engl J Med ; 390(15): 1394-1407, 2024 04 18.
Artigo em Inglês | MEDLINE | ID: mdl-38587233

RESUMO

BACKGROUND: Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group. CONCLUSIONS: Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.).


Assuntos
Diabetes Mellitus Tipo 2 , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon , Peptídeos Semelhantes ao Glucagon , Insuficiência Cardíaca , Obesidade , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/etiologia , Método Duplo-Cego , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/efeitos adversos , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/etiologia , Obesidade/complicações , Obesidade/tratamento farmacológico , Volume Sistólico , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon/administração & dosagem , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon/efeitos adversos , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon/uso terapêutico
3.
Circulation ; 149(19): 1474-1489, 2024 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-38533643

RESUMO

BACKGROUND: Heart failure triggers a shift in myocardial metabolic substrate utilization, favoring the ketone body 3-hydroxybutyrate as energy source. We hypothesized that 14-day treatment with ketone ester (KE) would improve resting and exercise hemodynamics and exercise capacity in patients with heart failure with reduced ejection fraction. METHODS: In a randomized, double-blind cross-over study, nondiabetic patients with heart failure with reduced ejection fraction received 14-day KE and 14-day isocaloric non-KE comparator regimens of 4 daily doses separated by a 14-day washout period. After each treatment period, participants underwent right heart catheterization, echocardiography, and blood sampling at plasma trough levels and after dosing. Participants underwent an exercise hemodynamic assessment after a second dosing. The primary end point was resting cardiac output (CO). Secondary end points included resting and exercise pulmonary capillary wedge pressure and peak exercise CO and metabolic equivalents. RESULTS: We included 24 patients with heart failure with reduced ejection fraction (17 men; 65±9 years of age; all White). Resting CO at trough levels was higher after KE compared with isocaloric comparator (5.2±1.1 L/min versus 5.0±1.1 L/min; difference, 0.3 L/min [95% CI, 0.1-0.5), and pulmonary capillary wedge pressure was lower (8±3 mm Hg versus 11±3 mm Hg; difference, -2 mm Hg [95% CI, -4 to -1]). These changes were amplified after KE dosing. Across all exercise intensities, KE treatment was associated with lower mean exercise pulmonary capillary wedge pressure (-3 mm Hg [95% CI, -5 to -1] ) and higher mean CO (0.5 L/min [95% CI, 0.1-0.8]), significantly different at low to moderate steady-state exercise but not at peak. Metabolic equivalents remained similar between treatments. In exploratory analyses, KE treatment was associated with 18% lower NT-proBNP (N-terminal pro-B-type natriuretic peptide; difference, -98 ng/L [95% CI, -185 to -23]), higher left ventricular ejection fraction (37±5 versus 34±5%; P=0.01), and lower left atrial and ventricular volumes. CONCLUSIONS: KE treatment for 14 days was associated with higher CO at rest and lower filling pressures, cardiac volumes, and NT-proBNP levels compared with isocaloric comparator. These changes persisted during exercise and were achieved on top of optimal medical therapy. Sustained modulation of circulating ketone bodies is a potential treatment principle in patients with heart failure with reduced ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05161650.


Assuntos
Insuficiência Cardíaca , Volume Sistólico , Humanos , Masculino , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/fisiopatologia , Feminino , Método Duplo-Cego , Idoso , Volume Sistólico/efeitos dos fármacos , Pessoa de Meia-Idade , Estudos Cross-Over , Tolerância ao Exercício/efeitos dos fármacos , Administração Oral , Função Ventricular Esquerda/efeitos dos fármacos , Resultado do Tratamento , Ésteres/administração & dosagem , Cetonas/administração & dosagem
4.
Circulation ; 2024 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-39101201

RESUMO

BACKGROUND: Systemic arterial compliance and venous capacitance are typically impaired in patients with heart failure with preserved ejection fraction (HFpEF), contributing to hemodynamic congestion with stress. Sodium-glucose cotransporter-2 inhibitors reduce hemodynamic congestion and improve clinical outcomes in patients with HFpEF, but the mechanisms remain unclear. This study tested the hypothesis that Dapagliflozin would improve systemic arterial compliance and venous capacitance during exercise in patients with HFpEF. METHODS: In this secondary analysis from the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial, 37 patients with HFpEF (mean age 68 ± 9 years, women 65%) underwent invasive hemodynamic exercise testing with simultaneous echocardiography at baseline and following treatment for 24 weeks with Dapagliflozin or placebo. Radial artery pressure (BP) was measured continuously using a fluid-filled catheter with transformation to aortic pressure, central hemodynamics were measured using high-fidelity micromanometers, and stressed blood volume was estimated from hemodynamic indices fit to a comprehensive cardiovascular model. RESULTS: There was no statistically significant effect of Dapagliflozin on resting BP, but Dapagliflozin reduced systolic BP during peak exercise (estimated treatment difference [ETD], -18.8 mm Hg [95% CI, -33.9 to -3.7] P=0.016). Reduction in BP was related to improved exertional total arterial compliance (ETD, 0.06 mL/mm Hg/m2 [95% CI, 0.003-0.11] P=0.039) and aortic root characteristic impedance (ETD, -2.6 mm Hg/mL*sec [95% CI: -5.1 to -0.03] P=0.048), with no significant effect on systemic vascular resistance. Dapagliflozin reduced estimated stressed blood volume at rest and during peak exercise (ETD, -292 mm Hg [95% CI, -530 to -53] P=0.018), and improved venous capacitance evidenced by a decline in ratio of estimated stressed blood volume to total blood volume (ETD, -7.3% [95% CI, -13.3 to -1.3] P=0.020). Each of these effects of Dapagliflozin at peak exercise were also observed during matched 20W exercise intensity. Improvements in total arterial compliance and estimated stressed blood volume were correlated with decreases in body weight, and reduction in systolic BP with treatment was correlated with the change in estimated stressed blood volume during exercise (r=0.40, P=0.019). Decreases in BP were correlated with reduction in pulmonary capillary wedge pressure during exercise (r=0.56, P<0.001). CONCLUSIONS: In patients with HFpEF, treatment with Dapagliflozin improved systemic arterial compliance and venous capacitance during exercise, while reducing aortic characteristic impedance, suggesting a reduction in arterial wall stiffness. These vascular effects may partially explain the clinical benefits with sodium-glucose cotransporter-2 inhibitors in HFpEF. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04730947.

5.
Lancet ; 403(10437): 1635-1648, 2024 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-38599221

RESUMO

BACKGROUND: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups. METHODS: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m2, New York Heart Association class II-IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatment effects was assessed across subgroups of interest. We assessed safety in all participants who received at least one dose of study drug. FINDINGS: Between March 19, 2021 and March 9, 2022, 529 people were randomly assigned in STEP-HFpEF, and between June 27, 2021 and Sept 2, 2022, 616 were randomly assigned in STEP-HFpEF DM. Overall, 1145 were included in our pooled analysis, 573 in the semaglutide group and 572 in the placebo group. Improvements in KCCQ-CSS and reductions in bodyweight between baseline and week 52 were significantly greater in the semaglutide group than in the placebo group (mean between-group difference for the change from baseline to week 52 in KCCQ-CSS 7·5 points [95% CI 5·3 to 9·8]; p<0·0001; mean between-group difference in bodyweight at week 52 -8·4% [-9·2 to -7·5]; p<0·0001). For the confirmatory secondary endpoints, 6-min walk distance (mean between-group difference at week 52 17·1 metres [9·2 to 25·0]) and the hierarchical composite endpoint (win ratio 1·65 [1·42 to 1·91]) were significantly improved, and CRP concentrations (treatment ratio 0·64 [0·56 to 0·72]) were significantly reduced, in the semaglutide group compared with the placebo group (p<0·0001 for all comparisons). For the dual primary endpoints, the efficacy of semaglutide was largely consistent across multiple subgroups, including those defined by age, race, sex, BMI, systolic blood pressure, baseline CRP, and left ventricular ejection fraction. 161 serious adverse events were reported in the semaglutide group compared with 301 in the placebo group. INTERPRETATION: In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction. These effects were largely consistent across patient demographic and clinical characteristics. Semaglutide was well tolerated. FUNDING: Novo Nordisk.


Assuntos
Peptídeos Semelhantes ao Glucagon , Insuficiência Cardíaca , Obesidade , Volume Sistólico , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Masculino , Volume Sistólico/efeitos dos fármacos , Feminino , Idoso , Pessoa de Meia-Idade , Método Duplo-Cego , Obesidade/complicações , Obesidade/tratamento farmacológico , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
Eur Heart J ; 2024 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-38739118

RESUMO

BACKGROUND AND AIMS: In the STEP-HFpEF trial program, treatment with semaglutide resulted in multiple beneficial effects in patients with obesity-related heart failure with preserved ejection fraction (HFpEF). Efficacy may vary according to baseline diuretic use, and semaglutide treatment could modify diuretic dose. METHODS: In this pre-specified analysis of pooled data from the STEP-HFpEF and STEP-HFpEF-DM trials (n=1145), which randomized participants with HFpEF and body mass index ≥30 kg/m2 to once weekly semaglutide 2.4 mg or placebo for 52 weeks, we examined whether efficacy and safety endpoints differed by baseline diuretic use, as well as the effect of semaglutide on loop diuretic use and dose changes over the 52-week treatment period. RESULTS: At baseline, across no diuretic (n=220), non-loop diuretic only (n=223), and loop diuretic (<40 [n=219], 40 [n=309], and >40 [n=174] mg/day furosemide-equivalents) groups, there was progressively higher prevalence of hypertension and atrial fibrillation; and severity of obesity and heart failure. Over 52 weeks of treatment, semaglutide had a consistent beneficial effect on change in body weight across diuretic use categories (adjusted mean difference vs. placebo ranged from -8.8% [95% CI -10.3, -6.3] to -6.9% [95% CI -9.1, -4.7] from no diuretics to the highest loop diuretic dose category; interaction P=0.39). Kansas City Cardiomyopathy Questionnaire clinical summary score improvement was greater in patients on loop diuretics compared to those not on loop diuretics (adjusted mean difference vs. placebo: +9.3 [6.5; 12.1] vs. +4.7 points [1.3, 8.2]; P=0.042). Semaglutide had consistent beneficial effects on all secondary efficacy endpoints (including 6-min walk distance) across diuretic subgroups (interaction P=0.24-0.92). Safety also favored semaglutide versus placebo across the diuretic subgroups. From baseline to 52 weeks, loop diuretic dose decreased by 17% in the semaglutide group vs. a 2.4% increase in the placebo group (P<0.0001). Semaglutide (vs. placebo) was more likely to result in loop diuretic dose reduction (odds ratio [OR] 2.67 [95% CI 1.70, 4.18]) and less likely dose increase (OR 0.35 [95% CI 0.23, 0.53]; P<0.001 for both) from baseline to 52 weeks. CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide improved heart failure-related symptoms and physical limitations across diuretic use subgroups, with more pronounced benefits among patients receiving loop diuretics at baseline. Reductions in weight and improvements in exercise function with semaglutide versus placebo were consistent in all diuretic use categories. Semaglutide also led to a reduction in loop diuretic use and dose between baseline and 52 weeks. CLINICALTRIALS.GOV REGISTRATION: NCT04788511 and NCT04916470.

7.
J Card Fail ; 30(7): 877-889, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38211934

RESUMO

OBJECTIVE: Splanchnic vasoconstriction augments transfer of blood volume from the abdomen into the thorax, which may increase filling pressures and hemodynamic congestion in patients with noncompliant hearts. Therapeutic interruption of splanchnic nerve activity holds promise to reduce hemodynamic congestion in patients with heart failure with preserved ejection fraction (HFpEF). Here we describe (1) the rationale and design of the first sham-controlled, randomized clinical trial of splanchnic nerve ablation for HFpEF and (2) the 12-month results of the lead-in (open-label) trial's participants. METHODS: REBALANCE-HF is a prospective, multicenter, randomized, double-blinded, sham-controlled clinical trial of endovascular, transcatheter, right-sided greater splanchnic nerve ablation for volume management (SAVM) in patients with HFpEF. The primary objectives are to evaluate the safety and efficacy of SAVM and identify responder characteristics to inform future studies. The trial consists of an open-label lead-in phase followed by the randomized, sham-controlled phase. The primary efficacy endpoint is the reduction in pulmonary capillary wedge pressure (PCWP) at 1-month follow-up compared to baseline during passive leg raise and 20W exercise. Secondary and exploratory endpoints include health status (Kansas City Cardiomyopathy Questionnaire), 6-minute walk test distance, New York Heart Association class, and NTproBNP levels at 3, 6 and 12 months. The primary safety endpoint is device- or procedure-related serious adverse events at the 1-month follow-up. RESULTS: The lead-in phase of the study, which enrolled 26 patients with HFpEF who underwent SAVM, demonstrated favorable safety outcomes and reduction in exercise PCWP at 1 month post-procedure and improvements in all secondary endpoints at 6 and 12 months of follow-up. The randomized phase of the trial (n = 44 SAVM; n = 46 sham) has completed enrollment, and follow-up is ongoing. CONCLUSION: REBALANCE-HF is the first sham-controlled randomized clinical trial of greater splanchnic nerve ablation in HFpEF. Initial 12-month open-label results are promising, and the results of the randomized portion of the trial will inform the design of a future pivotal clinical trial. SAVM may offer a promising therapeutic option for patients with HFpEF. TRIAL REGISTRATION: NCT04592445.


Assuntos
Insuficiência Cardíaca , Nervos Esplâncnicos , Volume Sistólico , Humanos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/cirurgia , Insuficiência Cardíaca/terapia , Volume Sistólico/fisiologia , Método Duplo-Cego , Nervos Esplâncnicos/cirurgia , Masculino , Feminino , Estudos Prospectivos , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Idoso , Pessoa de Meia-Idade , Técnicas de Ablação/métodos , Seguimentos
8.
Arch Sex Behav ; 53(5): 1695-1711, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38684620

RESUMO

Several aspects of clinical management of 46,XX congenital adrenal hyperplasia (CAH) remain unsettled and controversial. The North American Disorders/Differences of Sex Development (DSD) Clinician Survey investigated changes, over the last two decades, in clinical recommendations by specialists involved in the management of newborns with DSD. Members of the (Lawson Wilkins) Pediatric Endocrine Society and the Societies for Pediatric Urology participated in a web-based survey at three timepoints: 2003-2004 (T1, n = 432), 2010-2011 (T2, n = 441), and 2020 (T3, n = 272). Participants were presented with two clinical case scenarios-newborns with 46,XX CAH and either mild-to-moderate or severe genital masculinization-and asked for clinical recommendations. Across timepoints, most participants recommended rearing the newborn as a girl, that parents (in consultation with physicians) should make surgical decisions, performing early genitoplasty, and disclosing surgical history at younger ages. Several trends were identified: a small, but significant shift toward recommending a gender other than girl; recommending that adolescent patients serve as the genital surgery decision maker; performing genital surgery at later ages; and disclosing surgical details at younger ages. This is the first study assessing physician recommendations across two decades. Despite variability in the recommendations, most experts followed CAH clinical practice guidelines. The observation that some of the emerging trends do not align with expert opinion or empirical evidence should serve as both a cautionary note and a call for prospective studies examining patient outcomes associated with these changes.


Assuntos
Hiperplasia Suprarrenal Congênita , Humanos , Feminino , Masculino , Inquéritos e Questionários , Recém-Nascido , América do Norte , Adolescente , Padrões de Prática Médica , Transtornos do Desenvolvimento Sexual/cirurgia , Adulto
9.
Arch Sex Behav ; 53(8): 2939-2956, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39039338

RESUMO

Clinical decision-making for individuals with 46,XY disorders/differences of sex development (DSD) remains unsettled and controversial. The North American DSD Clinician Survey examines the recommendations of a large group of clinical specialists over the last two decades. Active members of the (Lawson Wilkins) Pediatric Endocrine Society and the Societies for Pediatric Urology were invited to respond to a web-based survey at three different timepoints: 2003-2004 (T1), 2010-2011 (T2), and 2019-2020 (T3). Data from 429 participants in T1, 435 in T2, and 264 in T3 were included in this study. The participants were presented with three XY newborn clinical case scenarios-micropenis, partial androgen insensitivity syndrome, and iatrogenic penile ablation-and asked for clinical management recommendations. The main outcomes assessed included the recommended gender of rearing, surgical decision-maker (parent or patient), timing of genital surgery, and age at which to disclose medical details and surgical history to the patient. For all scenarios, the overwhelming majority recommended rearing as male, including a significant increase across timepoints in those recommending a male gender of rearing for the infant with penile ablation. The proportions recommending female gender of rearing declined significantly across timepoints. In general, most recommended parents (in consultation with the physician) serve as surgical decision-makers, but these proportions declined significantly across timepoints. Recommendations on the timing of surgery varied based on the patient's gender and type of surgery. There has been a shift in recommendations away from the "optimal gender policy" regarding gender of rearing and surgical interventions for patients with XY DSD.


Assuntos
Transtorno 46,XY do Desenvolvimento Sexual , Humanos , Masculino , Feminino , Endocrinologistas , Urologistas , América do Norte , Recém-Nascido , Tomada de Decisão Clínica , Adulto , Padrões de Prática Médica/estatística & dados numéricos , Inquéritos e Questionários , Criança
10.
Int Urogynecol J ; 2024 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-38811409

RESUMO

Recently, the debate surrounding the use of mesh in urogynecological procedures has intensified, leading to FDA warnings and heightened safety concerns. This clinical opinion emphasizes the vital need to specify mesh types in these procedures, drawing attention to the risk profiles and clinical outcomes associated with various meshes and the procedures that utilize them. A significant issue identified in contemporary literature is the tendency to group diverse mesh types under the same umbrella, disregarding their unique characteristics and applications. We describe the range of mesh types, their application routes, and associated complications, highlighting the risks of this nonspecific approach to patient safety and informed decision making. We critically examine the generalization of mesh terminology in clinical and research dialogues. Concluding with specific recommendations for health care providers and researchers, the paper advocates for a more nuanced understanding and communication in the field, ultimately aiming to improve patient care and safety in urogynecological practice.

11.
Scand J Med Sci Sports ; 34(8): e14708, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-39165228

RESUMO

OBJECTIVES: Flexibility is recognized as one of the components of physical fitness and commonly included as part of exercise prescriptions for all ages. However, limited data exist regarding the relationship between flexibility and survival. We evaluated the sex-specific nature and magnitude of the associations between body flexibility and natural and non-COVID-19 mortality in a middle-aged cohort of men and women. DESIGN: Prospective cohort study. METHODS: Anthropometric, health and vital data from 3139 (66% men) individuals aged 46-65 years spanning from March 1994 to October 2022 were available. A body flexibility score, termed Flexindex, was derived from a combination of 20 movements (scored 0-4) involving seven different joints, resulting in a score range of 0-80. Kaplan-Meier survival curves were obtained, and unadjusted and adjusted hazard ratios (HRs) for mortality estimated. RESULTS: During a mean follow-up of 12.9 years, 302 individuals (9.6%) comprising 224 men/78 women died. Flexindex was 35% higher in women compared to men (mean ± SD: 41.1 ± 9.4 vs. 30.5 ± 8.7; p < 0.001) and exhibited an inverse relationship with mortality risk in both sexes (p < 0.001). Following adjustment for age, body mass index, and health status, the HR (95% CI) for mortality comparing upper and bottom of distributions of Flexindex were 1.87 (1.50-2.33; p < 0.001) for men and 4.78 (1.23-31.71; p = 0.047) for women. CONCLUSIONS: A component of physical fitness-body flexibility-as assessed by the Flexindex is strongly and inversely associated with natural and non-COVID-19 mortality risk in middle-aged men and women. Future studies should assess whether training-induced flexibility gains are related to longer survival.


Assuntos
Aptidão Física , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Idoso , Fatores Sexuais , Amplitude de Movimento Articular , Estimativa de Kaplan-Meier , Modelos de Riscos Proporcionais , Mortalidade , COVID-19/mortalidade
12.
Brain Inj ; 38(9): 742-749, 2024 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-38695288

RESUMO

BACKGROUND: The use of Environmental Enrichment (EE) has been widely studied in animal models. However, the application of the same in humans is limited to rehabilitation settings. OBJECTIVE: To investigate the feasibility of a community-based EE paradigm in adults with brain injury. METHODS: Six individuals diagnosed with traumatic brain injury enrolled in the study. The Go Baby Go Café instrumented with a body weight harness system, provided physical and social enrichment as participants performed functional tasks for 2 hours, three times a week, for 2 months. Feasibility and safety outcomes were recorded throughout sessions. Clinical measures including 10-meter walk, timed up and go, jebsen hand function, 6-minute walk, and trail making tests were obtained pre and post intervention. RESULTS: All participants completed the study. The attendance was 100% and adherence was 87%. Positive changes in clinical measures were statistically significant for the timed up and go (p = 0.0175), TUG-cognitive (p = 0.0064), 10-meter walk (p = 0.0428), six-minute walk (p = 0.0196), TMT-A (p = 0.034). Changes in JHFT were not significant (p = 0.0506), with one subject recording values counter to the trend. CONCLUSION: The Café was a comprehensive EE-based intervention that was feasible, safe, and has the potential to enhance motor and cognitive function in individuals with brain injury.


Assuntos
Lesões Encefálicas Traumáticas , Estudos de Viabilidade , Humanos , Masculino , Projetos Piloto , Feminino , Adulto , Lesões Encefálicas Traumáticas/reabilitação , Pessoa de Meia-Idade , Meio Ambiente , Resultado do Tratamento , Adulto Jovem
13.
Brain Inj ; 38(4): 288-294, 2024 03 20.
Artigo em Inglês | MEDLINE | ID: mdl-38369869

RESUMO

OBJECTIVE: The purpose of this study was to assess changes in concussion knowledge and attitudes amongst incoming intercollegiate student-athletes over the course of a decade (2010-2012 vs 2021-2023). METHODS: There were 592 student-athletes from 2 cohorts (2010-2012, 2021-2023) who completed the Rosenbaum Concussion Knowledge and Attitudes Survey (ROCKaS) questionnaire which is comprised of a concussion knowledge index (CKI, 0-24) and attitude index (CAI, 15-75) with higher scores reflecting better performance. A three factor ANOVA (Group, Sex, Concussion History) compared performance on the CKI and CAI. Individual questions were compared between groups with a Chi-Square analysis. RESULTS: For the CKI, there was a significant main effect for Group (2010-2012: 18.5 ± 2.6, 2021-2023: 19.4 ± 2.5, p < 0.001, η2=0.032). For the CAI, there was also a significant main effect for group (2010-2012: 52.9 ± 6.0, 2021-2023: 62.2 ± 6.5, p < 0.001, η2=0.359). CONCLUSIONS: The results of this study show a modest increase in concussion knowledge; however, large improvements in concussion attitudes were observed between groups. These results suggest a continued improvement in student-athlete concussion awareness and provide specific areas to continue addressing persistent misconceptions.


Assuntos
Traumatismos em Atletas , Concussão Encefálica , Humanos , Concussão Encefálica/diagnóstico , Inquéritos e Questionários , Atletas , Estudantes , Conhecimentos, Atitudes e Prática em Saúde
14.
Arch Gynecol Obstet ; 309(6): 2915-2920, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38517505

RESUMO

PURPOSE: Pelvic organ prolapse (POP) and overactive bladder (OAB) commonly affect the aging female population. We aimed to investigate the possible relationship between the two, as reflected by urodynamic studies. METHODS: A retrospective analysis was conducted on women who underwent urodynamic studies at a university-affiliated tertiary medical center from January 2018 to January 2021. Women presenting with urge incontinence and diagnosed with detrusor overactivity (DO) were included in the study. Based on the presence or absence of a modified POP-Q ≥ grade 2, these women were categorized into two groups. Data on general demographics, clinical symptoms, and urodynamic findings were extracted and compared using SPSS. RESULTS: During the study period, 949 urodynamic evaluations were performed. Of these, 303 (31.92%) reported urge incontinence. Out of this subset, 151 (49.83%) were diagnosed with DO. Within this group, 18 (11.9%) had POP, while 134 (88.1%) did not. The POP group had a notably higher incidence of prior vaginal hysterectomy and anterior colporrhaphy (p = 0.02 and p = 0.01, respectively). While most urodynamic parameters were similar between groups, there was a significant increase in hesitancy in the POP group (13 s vs 8 s, p = 0.03). There was a trend indicating a reduced median Q max (12 ml/s vs. 18 ml/s, p = 0.06) and an increased flow time (55 s vs 40 s, p = 0.08) in the POP group. CONCLUSION: The urodynamic profile of the POP group suggests an obstructive voiding pattern. Further longitudinal research is essential to fully understand the relationship between POP and OAB.


Assuntos
Prolapso de Órgão Pélvico , Bexiga Urinária Hiperativa , Incontinência Urinária de Urgência , Urodinâmica , Humanos , Feminino , Prolapso de Órgão Pélvico/fisiopatologia , Prolapso de Órgão Pélvico/complicações , Prolapso de Órgão Pélvico/cirurgia , Bexiga Urinária Hiperativa/fisiopatologia , Bexiga Urinária Hiperativa/complicações , Estudos Retrospectivos , Pessoa de Meia-Idade , Incontinência Urinária de Urgência/fisiopatologia , Incontinência Urinária de Urgência/epidemiologia , Idoso , Adulto
15.
Alzheimers Dement ; 20(5): 3179-3192, 2024 05.
Artigo em Inglês | MEDLINE | ID: mdl-38491912

RESUMO

BACKGROUND: With the availability of disease-modifying therapies for Alzheimer's disease (AD), it is important for clinicians to have tests to aid in AD diagnosis, especially when the presence of amyloid pathology is a criterion for receiving treatment. METHODS: High-throughput, mass spectrometry-based assays were used to measure %p-tau217 and amyloid beta (Aß)42/40 ratio in blood samples from 583 individuals with suspected AD (53% positron emission tomography [PET] positive by Centiloid > 25). An algorithm (PrecivityAD2 test) was developed using these plasma biomarkers to identify brain amyloidosis by PET. RESULTS: The area under the receiver operating characteristic curve (AUC-ROC) for %p-tau217 (0.94) was statistically significantly higher than that for p-tau217 concentration (0.91). The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status. DISCUSSION: The PrecivityAD2 blood test showed strong clinical validity, with excellent agreement with brain amyloidosis by PET.


Assuntos
Algoritmos , Doença de Alzheimer , Peptídeos beta-Amiloides , Biomarcadores , Encéfalo , Espectrometria de Massas , Fragmentos de Peptídeos , Tomografia por Emissão de Pósitrons , Proteínas tau , Humanos , Peptídeos beta-Amiloides/sangue , Feminino , Masculino , Proteínas tau/sangue , Doença de Alzheimer/sangue , Doença de Alzheimer/diagnóstico , Doença de Alzheimer/diagnóstico por imagem , Idoso , Fragmentos de Peptídeos/sangue , Encéfalo/diagnóstico por imagem , Encéfalo/metabolismo , Biomarcadores/sangue , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Curva ROC
16.
Psychother Res ; : 1-11, 2024 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-38718140

RESUMO

OBJECTIVE: Positive regard (PR) reflects a therapist's unconditional prizing of their patient, which meta-analytically correlates positively with patient improvement. However, most research has been limited to single-participant ratings of PR at a specific time, which neglects the dyadic and dynamic nature of PR (i.e., fundamental to benefitting from therapist-offered PR is that a patient internalizes it). Testing this premise, we hypothesized that therapist-offered PR at one session would predict patient-felt PR at a subsequent session (two sessions later), which would in turn predict the patient's next-session outcome (within-patient mediation). METHOD: Eighty-four patients with generalized anxiety disorder received cognitive-behavioral therapy with or without motivational interviewing. Therapists and patients provided postsession ratings of their offered and felt PR, respectively, at odd-numbered sessions throughout treatment. Patients rated their worry following each even-numbered session. We used multilevel structural equation modeling to test our hypothesis. We explored whether treatment condition moderated the mediational path. RESULTS: As predicted, when a therapist regarded their patient more than usual following one session, the patient felt more regarded than usual. In turn, this internalized regard was negatively associated with worry. Treatment condition did not moderate this path. DISCUSSION: Results support internalized positive regard as a treatment-common, ameliorative relationship process.

17.
J Trauma Nurs ; 31(2): 104-108, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38484166

RESUMO

BACKGROUND: Comprehensive and multidisciplinary discharge planning can improve trauma patient throughput, decrease length of hospitalization, increase family and patient support, and expedite hospital discharge. OBJECTIVE: This study aimed to assess the feasibility and acceptability of implementing a patient-centered discharge plan form for adult trauma patients. METHODS: A single-center pilot study was conducted with adult trauma patients on a neurosurgical medical-surgical floor at a Level II trauma center in the Western United States from January to February 2023. The study had three phases: observation, pilot intervention, and follow-up. The key pilot intervention was the development of a standardized patient-centered discharge plan form, pilot tested by a trauma advanced practice provider and an inpatient discharge nurse. The primary outcome was the frequency of discharge orders being written before noon on the day of discharge. Qualitative and quantitative outcomes are reported. RESULTS: The discharge form was used for eight patients during the pilot intervention phase; an advanced practice provider and an inpatient discharge nurse each completed the forms for four patients. Five of eight observed patients had discharge orders before noon; the incidence of orders before noon was slightly higher when the form was completed by the discharge nurse (three of four patients) than by the advanced practice provider (two of four patients). CONCLUSIONS: The pilot study found that the patient-centered discharge plan form was feasible and acceptable to help improve the discharge process for trauma patients. Additional work to further refine the form's content and administration is warranted.


Assuntos
Alta do Paciente , Centros de Traumatologia , Adulto , Humanos , Estados Unidos , Projetos Piloto , Hospitalização , Assistência Centrada no Paciente
18.
Artigo em Inglês | MEDLINE | ID: mdl-38529518

RESUMO

BACKGROUND: The Americans with Disabilities Act (ADA) is sweeping civil rights legislation that affords people with disabilities equality of opportunity, economic self-sufficiency, independent living, and full participation in daily life. The protections of the ADA extend to individuals with alcohol and substance abuse disorders who are in recovery. OBJECTIVE: The objective of this article is to understand the ADA's definition of disability and how it applies to addiction and recovery. The reader will recognize how the ADA applies to people with addiction to alcohol and those in recovery from substance abuse. The article will describe the rights and responsibilities employers and employees have in the three stages of employment. METHOD: The material in this presentation was developed based on the authors' research, training, education, knowledge, and skill of the ADA. RESULTS: Individuals in recovery are often unaware of their civil rights under the ADA. The ADA ensures that people with disabilities, including those with alcohol use disorder and substance use disorders, have the same rights and opportunities in the workplace. CONCLUSION: The COVID-19 pandemic has resulted in an increase in increased rates of alcoholism and substance abuse. Individuals living with addiction are unaware of the employment protections they may have under the ADA. Title I of the ADA guarantees employment protections to ensure equality in the workplace for people with disabilities. A clearer understanding of the law will ensure that job seekers and employees are treated in an ethical, valued, and courteous way when disclosing disability and the need for accommodation.

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